An interventional study of Experimental diet Fru rich diet and Experimental low Fru diet in Hereditary Fructose Intolerance, sponsored by University of Lausanne. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by University of Lausanne · Not applicable, Interventional, and Prevention
This study aimed to examine metabolic response to a short-term fructose enriched diet in carriers for hereditary fructose intolerance compared to controls. Effects of fructose coffees will be assessed in 7 healthy volunteers and 7 subjects with heterozygous mutation for ALDOB gene in a randomized, controlled, crossover trial.
A high fructose intake also increases blood lactate and uric acid concentrations. It has been proposed that uric acid may contribute to insulin resistance by impairing endothelium-dependent vasodilation, promoting pro-inflammatory effects and dyslipidemia by activating de novo lipogenesis.
These consequences of fructose overconsumption may be even more marked in individuals with hereditary alterations in fructose metabolism. Indeed, individuals with hereditary fructose intolerance (HFI), due to biallelic mutations in the gene coding for aldolase B (ALDOB), may develop acute, life-threatening manifestations when exposed to fructose. Heterozygous carriers of ALDOB mutation are quite common in the general population, with a predicted frequency ranging between 1:55 and 1:120. Few studies have examined the effect of fructose ingestion in heterozygotes subject for HFI. Heterozygous carriers are generally considered to have normal fructose metabolism since a \~ 50% level of aldolase B activity is presumed to be sufficient for adequate function. However, heterozygous carriers were reported to have enhanced uric acid responses to large intravenous and/or oral fructose loads.
Investigators hypothesized that heterozygous carriers may also have mild defects of fructose metabolism and/or a larger increase in cardiometabolic risk factors than the normal population after ingestion of moderate amounts of fructose.
University of Lausanne is the lead sponsor of 54 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Enriched fructose diet from day 1 to day 7.
Other: Experimental diet Fru rich diet
Low fructose diet from day 1 to day 7.
Other: Experimental low Fru diet
7 days (day 1 to day 7) with fructose enriched drinks 3x/d. Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
7 days (day 1 to day 7) with low-fructose diet (\<10g/d). Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
Metabolite concentration
The primary endpoint is the change of metabolite concentration after ingestion of a test meal (oral glucose and fructose load) under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma glucose concentration
Change in glucose concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma insulin concentration
Change in insulin concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma fructose concentration
Change in fructose concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma uric acid concentration
Change in uric acid concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma lactate concentration
Change in lactate concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma urea concentration
Change in urea concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma creatinine concentration
Change in creatinine concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma phosphate concentration
Change in phosphate concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma triglycerides concentration
Change in triglycerides concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma metabolome concentration
Change in metabolome concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma ammonia concentration
Change in ammonia concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma amino acid concentration
Change in amino acid concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma alanine transaminase (ALAT) concentration
Change in alanine transminase (ALAT) concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Plasma aspartate transaminase (ASAT) concentration
Change in aspartate transaminase (ASAT) concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
Urine metabolome concentration
Change in urine metabolome profile after low fructose diet and an enriched fructose diet according to a crossover design
Time frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Urine creatinine concentration
Change in urine creatinine profile after low fructose diet and an enriched fructose diet according to a crossover design
Time frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Urine urea concentration
Change in urine urea profile after low fructose diet and an enriched fructose diet according to a crossover design
Time frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Urine uric acid concentration
Change in urine uric acid profile after low fructose diet and an enriched fructose diet according to a crossover design
Time frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Body weight
Change of body weight after low fructose diet and an enriched fructose diet according to a crossover design
Time frame: Time Frame: at baseline before study intervention and at the end of each conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
Blood pressure
Change of systolic and diastolic pressure after low fructose diet and an enriched fructose diet according to a crossover design
Time frame: Time Frame: at baseline before study intervention and at the end of each conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Fructose Intolerance
University of Lausanne